Continuous analyte monitor data recording device operable in a blinded mode

ABSTRACT

A system is provided including a continuous analyte sensor that produces a data stream indicative of a host&#39;s analyte concentration and a device that receives and records data from the data stream from the continuous analyte sensor. The data received from the continuous analyte sensor may be used to provide alarms to the user when the analyte concentration and/or the rate of change of analyte concentration, as measured by the continuous analyte sensor, is above or below a predetermined range. Data received from the continuous analyte sensor may also be used to prompt the diabetic or caregiver to take certain actions, such as to perform another single point blood glucose measurement. The device may provide for toggling between modes that allow or prevent the display of glucose concentration values associated with the continuous glucose sensor.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority under 35 U.S.C. Section 119(e) to U.S.Provisional Application 61/407,412, filed on Oct. 27, 2010. Thedisclosure of this application is hereby incorporated by reference inits entirety.

FIELD OF THE INVENTION

The embodiments described herein relate generally to a system includinga continuous analyte sensor and a device configured to communicate withand record data from the continuous analyte sensor, and to provide asingle point analyte measurement.

BACKGROUND OF THE INVENTION

Diabetes mellitus is a chronic disease, which occurs when the pancreasdoes not produce enough insulin (Type I), or when the body cannoteffectively use the insulin it produces (Type II). This conditiontypically leads to an increased concentration of glucose in the blood(hyperglycemia), which can cause an array of physiological derangements(e.g., kidney failure, skin ulcers, or bleeding into the vitreous of theeye) associated with the deterioration of small blood vessels.Sometimes, a hypoglycemic reaction (low blood sugar) is induced by aninadvertent overdose of insulin, or after a normal dose of insulin orglucose-lowering agent accompanied by extraordinary exercise orinsufficient food intake.

People with type 1 diabetes generally have to submit to a demandingdaily regimen that typically requires frequent monitoring of bloodglucose (BG) and dosing of insulin by injection or infusion pump, inorder to maintain safe blood sugar levels. Under current FDAregulations, a diabetic or caregiver can not make dosing decisions offof conventional continuous glucose monitoring (CGM) technology.Accordingly, even with the use of a conventional CGM system, thediabetic or a caregiver would still be required to double-check glucoselevels by using a blood glucose monitoring (BGM) device, in determiningwhether to administer insulin. Use of BGM devices traditionally involvespricking of a finger to obtain a small blood sample, which the diabeticor caregiver applies onto a strip that is inserted in the BGM device.

SUMMARY OF THE INVENTION

In a first aspect, a system for monitoring glucose concentration isprovided, the system comprising: a continuous glucose sensor, thecontinuous glucose sensor configured to continuously measure glucoseconcentration and output a data stream associated with glucoseconcentration; and a device configured to operatively connect with thecontinuous glucose sensor, the device comprising a single point glucosemonitor, at least one processor configured to process the data streamfrom the continuous glucose sensor, and a user interface configured todisplay measured glucose concentration values associated with the singlepoint glucose monitor.

In an embodiment of the first aspect, the device is configured to notdisplay glucose concentration values associated with the data streamfrom the continuous glucose sensor.

In an embodiment of the first aspect, the device is configured fortoggling between a first mode allowing for display of glucoseconcentration values associated with the continuous glucose sensor and asecond mode preventing display of glucose concentration valuesassociated with the continuous glucose sensor.

In an embodiment of the first aspect, the at least one processor isconfigured to determine when to trigger an alarm, wherein thedetermination of when to trigger the alarm is based at least in part oninformation associated with the processed data stream.

In an embodiment of the first aspect, the alarm is configured to warn auser of a pending hyperglycemic event or a pending hypoglycemic event.

In an embodiment of the first aspect, the at least one processor isconfigured to determine when to prompt a user to perform a single pointglucose measurement, wherein the determination of when to prompt theuser is based at least in part on information associated with theprocessed data stream.

In an embodiment of the first aspect, the continuous glucose sensor isan implantable device.

In an embodiment of the first aspect, the single point glucose monitoris configured to measure a glucose concentration in blood.

In an embodiment of the first aspect, the device further comprises amemory for recording at least one of the data stream from the continuousanalyte sensor or measured glucose concentration values associated withthe single point glucose monitor.

In a second aspect, a system for monitoring glucose concentration isprovided, the system comprising: a continuous glucose sensor, thecontinuous glucose sensor configured to continuously measure glucoseconcentration and output a data stream associated with glucoseconcentration; and a device configured to operatively connect with thecontinuous glucose sensor, the device comprising a single point glucosemonitor, at least one processor configured to process the data streamfrom the continuous glucose sensor, the at least one processorconfigured to determine when to prompt a user to perform a single pointglucose measurement, wherein the determination of when to prompt theuser is based at least in part on information associated with theprocessed data stream.

In an embodiment of the second aspect, the device is configured todisplay glucose concentration values associated with the single pointglucose monitor.

In an embodiment of the second aspect, the device is configured fortoggling between a first mode allowing for display of glucoseconcentration values associated with the continuous glucose sensor and asecond mode preventing display of glucose concentration valuesassociated with the continuous glucose sensor.

In an embodiment of the second aspect, the device is configured to notdisplay glucose concentration values associated with the data streamfrom the continuous glucose sensor.

In an embodiment of the second aspect, the at least one processor isfurther configured to determine when to trigger an alarm, wherein thedetermination of when to trigger the alarm is based at least in part oninformation associated with the processed data stream.

In an embodiment of the second aspect, the alarm is configured to warn auser of a pending hyperglycemic event or a pending hypoglycemic event.

In an embodiment of the second aspect, the continuous glucose sensor isan implantable device.

In an embodiment of the second aspect, the single point glucose monitoris configured to measure a glucose concentration in blood.

In an embodiment of the second aspect, the device further comprises amemory for recording at least one of the data stream from the continuousanalyte sensor or measured glucose concentration values associated withthe single point glucose monitor.

In a third aspect, a method for analyzing glucose concentration in auser is provided, the method comprising: receiving, from a continuousglucose sensor to a single point glucose monitor, a data streamassociated with glucose concentration; processing the data stream;recording the data stream; determining when to trigger an alarm, whereinthe determining of when to trigger the alarm is based at least in parton information associated with the processed data stream; anddetermining when to prompt a user to perform a single point glucosemeasurement, wherein the determining of when to perform the single pointglucose measurement is based at least in part on information associatedwith the processed data stream.

In an embodiment of the third aspect, the method further comprisestransferring the data stream from the single point glucose monitor to adevice.

In an embodiment of the third aspect, the method further comprisesperforming retrospective analysis on the data stream on the device.

In a fourth aspect, a method for monitoring glucose concentration in auser comprises receiving, from a continuous analyte sensor, a datastream associated with analyte concentration, processing the datastream, recording the data stream without displaying any informationassociated with or derived from the data stream, and triggering an alarmbased at least in part on information associated with the processed datastream.

In one embodiment of the fourth aspect, the alarm comprises a prompt toa user to perform a single point glucose measurement.

In another embodiment of the fourth aspect, the alarm comprises anotification of a hypoglycemic or hyperglycemic event.

In a fifth aspect, a system for continuous monitoring of an analyteconcentration in a host comprises a continuous analyte sensor and arecording device configured to receive a data stream representative ofanalyte concentration in the host. The recording device is configurableto operate in a mode that restricts host access to data from thecontinuous analyte sensor while still providing alarms to the host basedon data from the continuous analyte sensor.

In an embodiment of the fifth aspect, the recording device isconfigurable to operate in a second mode that allows host access to datafrom the continuous analyte sensor.

BRIEF DESCRIPTION OF THE DRAWINGS

Some of the figures shown herein are not necessarily drawn to scale.

FIG. 1 is a diagram illustrating one embodiment of a continuous analytesensor system including a sensor electronics module.

FIG. 2A is a perspective view of a sensor system including a mountingunit and sensor electronics module attached thereto according to oneembodiment.

FIG. 2B is a side view of the sensor system of FIG. 2B.

FIG. 3 is an exemplary block diagram illustrating various elements ofone embodiment of a continuous analyte sensor system and display device.

FIG. 4 is a block diagram illustrating one embodiment of the deviceelectronics.

FIG. 5 is a block diagram illustrating a system for storing andretrieving analyte information over a network.

FIG. 6 is a block diagram illustrating a typical architecture of a webserver that may implement one of the disclosed operative embodiments.

FIG. 7 is a flow chart illustrating a method of operating a continuousanalyte monitoring system.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The following description and examples describe in detail some exemplaryembodiments of sensors, devices, systems, and methods for using thesensors, devices, and systems described herein. There are numerousvariations and modifications of the sensors, devices, systems, andmethods described herein that are encompassed by the present invention.Accordingly, the description of a certain exemplary embodiment shouldnot be deemed to limit the scope of the present invention.

Definitions

In order to facilitate an understanding of the preferred embodiments, anumber of terms are defined below.

The term “analyte,” as used herein, is a broad term, and is to be givenits ordinary and customary meaning to a person of ordinary skill in theart (and is not to be limited to a special or customized meaning), andrefers without limitation to a substance or chemical constituent in abiological fluid (for example, blood, interstitial fluid, cerebralspinal fluid, lymph fluid, urine, sweat, saliva, etc.) that can beanalyzed. Analytes can include naturally occurring substances,artificial substances, metabolites, or reaction products. In someembodiments, the analyte for measurement by the sensing regions,devices, and methods is glucose. However, other analytes arecontemplated as well, including, but not limited to:acarboxyprothrombin; acylcarnitine; adenine phosphoribosyl transferase;adenosine deaminase; albumin; alpha-fetoprotein; amino acid profiles(arginine (Krebs cycle), histidine/urocanic acid, homocysteine,phenylalanine/tyrosine, tryptophan); andrenostenedione; antipyrine;arabinitol enantiomers; arginase; benzoylecgonine (cocaine);biotinidase; biopterin; c-reactive protein; carnitine; carnosinase; CD4;ceruloplasmin; chenodeoxycholic acid; chloroquine; cholesterol;cholinesterase; conjugated 1-β hydroxy-cholic acid; cortisol; creatinekinase; creatine kinase MM isoenzyme; cyclosporin A; d-penicillamine;de-ethylchloroquine; dehydroepiandrosterone sulfate; DNA (acetylatorpolymorphism, alcohol dehydrogenase, alpha 1-antitrypsin, cysticfibrosis, Duchenne/Becker muscular dystrophy, glucose-6-phosphatedehydrogenase, hemoglobin A, hemoglobin S, hemoglobin C, hemoglobin D,hemoglobin E, hemoglobin F, D-Punjab, beta-thalassemia, hepatitis Bvirus, HCMV, HIV-1, HTLV-1, Leber hereditary optic neuropathy, MCAD,RNA, PKU, Plasmodium vivax, sexual differentiation, 21-deoxycortisol);desbutylhalofantrine; dihydropteridine reductase; diptheria/tetanusantitoxin; erythrocyte arginase; erythrocyte protoporphyrin; esterase D;fatty acids/acylglycines; free β-human chorionic gonadotropin; freeerythrocyte porphyrin; free thyroxine (FT4); free tri-iodothyronine(FT3); fumarylacetoacetase; galactose/gal-1-phosphate;galactose-1-phosphate uridyltransferase; gentamicin; glucose-6-phosphatedehydrogenase; glutathione; glutathione perioxidase; glycocholic acid;glycosylated hemoglobin; halofantrine; hemoglobin variants;hexosaminidase A; human erythrocyte carbonic anhydrase I;17-alpha-hydroxyprogesterone; hypoxanthine phosphoribosyl transferase;immunoreactive trypsin; lactate; lead; lipoproteins ((a), B/A-1, β);lysozyme; mefloquine; netilmicin; phenobarbitone; phenytoin;phytanic/pristanic acid; progesterone; prolactin; prolidase; purinenucleoside phosphorylase; quinine; reverse tri-iodothyronine (rT3);selenium; serum pancreatic lipase; sissomicin; somatomedin C; specificantibodies (adenovirus, anti-nuclear antibody, anti-zeta antibody,arbovirus, Aujeszky's disease virus, dengue virus, Dracunculusmedinensis, Echinococcus granulosus, Entamoeba histolytica, enterovirus,Giardia duodenalisa, Helicobacter pylori, hepatitis B virus, herpesvirus, HIV-1, IgE (atopic disease), influenza virus, Leishmaniadonovani, leptospira, measles/mumps/rubella, Mycobacterium leprae,Mycoplasma pneumoniae, Myoglobin, Onchocerca volvulus, parainfluenzavirus, Plasmodium falciparum, poliovirus, Pseudomonas aeruginosa,respiratory syncytial virus, rickettsia (scrub typhus), Schistosomamansoni, Toxoplasma gondii, Trepenoma pallidium, Trypanosomacruzi/rangeli, vesicular stomatis virus, Wuchereria bancrofti, yellowfever virus); specific antigens (hepatitis B virus, HIV-1);succinylacetone; sulfadoxine; theophylline; thyrotropin (TSH); thyroxine(T4); thyroxine-binding globulin; trace elements; transferrin;UDP-galactose-4-epimerase; urea; uroporphyrinogen I synthase; vitamin A;white blood cells; and zinc protoporphyrin. Salts, sugar, protein, fat,vitamins, and hormones naturally occurring in blood or interstitialfluids can also constitute analytes in certain embodiments. The analytecan be naturally present in the biological fluid or endogenous, forexample, a metabolic product, a hormone, an antigen, an antibody, andthe like. Alternatively, the analyte can be introduced into the body orexogenous, for example, a contrast agent for imaging, a radioisotope, achemical agent, a fluorocarbon-based synthetic blood, or a drug orpharmaceutical composition, including but not limited to: insulin;ethanol; cannabis (marijuana, tetrahydrocannabinol, hashish); inhalants(nitrous oxide, amyl nitrite, butyl nitrite, chlorohydrocarbons,hydrocarbons); cocaine (crack cocaine); stimulants (amphetamines,methamphetamines, Ritalin, Cylert, Preludin, Didrex, PreState, Voranil,Sandrex, Plegine); depressants (barbituates, methaqualone, tranquilizerssuch as Valium, Librium, Miltown, Serax, Equanil, Tranxene);hallucinogens (phencyclidine, lysergic acid, mescaline, peyote,psilocybin); narcotics (heroin, codeine, morphine, opium, meperidine,Percocet, Percodan, Tussionex, Fentanyl, Darvon, Talwin, Lomotil);designer drugs (analogs of fentanyl, meperidine, amphetamines,methamphetamines, and phencyclidine, for example, Ecstasy); anabolicsteroids; and nicotine. The metabolic products of drugs andpharmaceutical compositions are also contemplated analytes. Analytessuch as neurochemicals and other chemicals generated within the body canalso be analyzed, such as, for example, ascorbic acid, uric acid,dopamine, noradrenaline, 3-methoxytyramine (3MT),3,4-dihydroxyphenylacetic acid (DOPAC), homovanillic acid (HVA),5-hydroxytryptamine (5HT), and 5-hydroxyindoleacetic acid (FHIAA).

The term “continuous,” as used herein in reference to analyte sensing,is a broad term, and is to be given its ordinary and customary meaningto a person of ordinary skill in the art (and is not to be limited to aspecial or customized meaning), and refers without limitation to thecontinuous, continual, or intermittent (e.g., regular) monitoring ofanalyte concentration, such as, for example, performing a measurementabout every 1 to 10 minutes.

The terms “membrane,” “membrane system,” or “sensing membrane,” as usedherein, are broad terms and are used in their ordinary sense, including,without limitation, a permeable or semi-permeable membrane that can becomprised of two or more domains and is typically constructed ofmaterials of a few microns thickness or more, which are permeable tooxygen and are optionally permeable to glucose. In one example, themembrane comprises an immobilized glucose oxidase enzyme, which enablesan electrochemical reaction to occur to measure a concentration ofglucose.

The term “host,” as used herein, is a broad term and is used in itsordinary sense, including, without limitation, mammals such as humans.

The term “electroactive surface,” as used herein, is a broad term, andis to be given its ordinary and customary meaning to a person ofordinary skill in the art (and is not to be limited to a special orcustomized meaning), and refers without limitation to the surface of anelectrode where an electrochemical reaction is to take place. As oneexample, in a working electrode, H₂O₂ (hydrogen peroxide) produced by anenzyme-catalyzed reaction of an analyte being detected reacts andthereby creates a measurable electric current. For example, in thedetection of glucose, glucose oxidase produces H₂O₂ as a byproduct. TheH₂O₂ reacts with the surface of the working electrode to produce twoprotons (2H⁺), two electrons (2e⁻), and one molecule of oxygen (O₂),which produces the electric current being detected. In the case of thecounter electrode, a reducible species, for example, O₂ is reduced atthe electrode surface in order to balance the current being generated bythe working electrode.

The term “sensing region,” as used herein, is a broad term, and is to begiven its ordinary and customary meaning to a person of ordinary skillin the art (and is not to be limited to a special or customizedmeaning), and refers without limitation to the region of a monitoringdevice responsible for the detection of a particular analyte.

The term “alarm,” as used herein, is a broad term, and is to be givenits ordinary and customary meaning to a person of ordinary skill in theart (and is not to be limited to a special or customized meaning), andrefers without limitation to an alert or signal, such as an audible,visual, or tactile signal, triggered in response to one or more alarmconditions. In one embodiment, hyperglycemic and hypoglycemic alarms aretriggered when present or predicted clinical danger is assessed based oncontinuous analyte data.

Overview

FIG. 1 is a block diagram of a system that includes a continuous analytesensor 10 coupled to sensor electronics 12 provided in or on an analytemeasuring module 8 configured for on-body mounting to a host. The module8 continuously measures analyte concentration in a host and provides adata stream that in one embodiment is representative of the host'sanalyte concentration. Additionally or alternatively, in anotherembodiment, the data stream may include data that is representative ofthe rate of change of the host's analyte concentration.

The continuous analyte sensor 10 measures a concentration of an analyte(e.g., glucose) or a species (e.g., hydrogen peroxide or oxygen)indicative of the concentration or presence of the analyte. In someembodiments, the continuous analyte sensor is an invasive,minimally-invasive, or non-invasive device, for example a subcutaneous,transcutaneous, or intravascular device. In some embodiments, the devicecan analyze a plurality of intermittent biological samples. Thecontinuous analyte sensor can use any method of analyte-measurement(e.g., glucose-measurement), including enzymatic, chemical, physical,electrochemical, spectrophotometric, polarimetric, calorimetric,radiometric, or the like. In alternative embodiments, the continuousanalyte sensor can be any sensor capable of determining theconcentration level of an analyte in the body, for example oxygen,lactase, hormones, cholesterol, medicaments, viruses, or the like.

The continuous analyte sensor may use any known method to provide anoutput signal indicative of the concentration of the analyte. The outputsignal is typically a data stream that is used to provide a value of themeasured analyte concentration or the measured rate of change of theanalyte concentration. One exemplary embodiment utilizes a subcutaneousglucose sensor as the continuous analyte sensor. However, the sensors,devices, systems, and methods described herein can be applied to anycontinuous analyte sensor capable of continually or continuouslydetecting a concentration of analyte of interest and providing an outputsignal that represents the concentration of that analyte.

FIGS. 2A and 2B are perspective and side views of a sensor module 8including a mounting unit 214 and sensor electronics module 12 attachedthereto in one embodiment, shown in its functional position, including amounting unit and a sensor electronics module matingly engaged therein.In some embodiments, the mounting unit 214, also referred to as ahousing or sensor pod, comprises a base 234 adapted for fastening to ahost's skin. The base can be formed from a variety of hard or softmaterials, and can comprises a low profile for minimizing protrusion ofthe device from the host during use. In some embodiments, the base 234is formed at least partially from a flexible material, which is believedto provide numerous advantages over conventional transcutaneous sensors,which, unfortunately, can suffer from motion-related artifactsassociated with the host's movement when the host is using the device.The mounting unit 214 and/or sensor electronics module 12 can be locatedover the sensor insertion site to protect the site and/or provide aminimal footprint (utilization of surface area of the host's skin).

In some embodiments, a detachable connection between the mounting unit214 and sensor electronics module 12 is provided, which enables improvedmanufacturability, namely, the relatively inexpensive mounting unit 214can be disposed of when replacing the sensor system after its usablelife, while the relatively more expensive sensor electronics module 12can be reusable with multiple sensor systems. In some embodiments, thesensor electronics module 12 is configured with signal processing(programming), for example, configured to filter, calibrate and/or otheralgorithms useful for calibration and/or display of sensor information.However, an integral (non-detachable) sensor electronics module can beconfigured.

In some embodiments, the contacts 238 are mounted on or in a subassemblyhereinafter referred to as a contact subassembly 236 configured to fitwithin the base 234 of the mounting unit 214 and a hinge 248 that allowsthe contact subassembly 236 to pivot between a first position (forinsertion) and a second position (for use) relative to the mounting unit214. The term “hinge” as used herein is a broad term and is used in itsordinary sense, including, without limitation, to refer to any of avariety of pivoting, articulating, and/or hinging mechanisms, such as anadhesive hinge, a sliding joint, and the like; the term hinge does notnecessarily imply a fulcrum or fixed point about which the articulationoccurs. In some embodiments, the contacts 238 are formed from aconductive elastomeric material, such as a carbon black elastomer,through which the sensor 10 extends.

In certain embodiments, the mounting unit 214 is provided with anadhesive pad 208, disposed on the mounting unit's back surface andincludes a releasable backing layer. Thus, removing the backing layerand pressing the base portion 234 of the mounting unit onto the host'sskin adheres the mounting unit 214 to the host's skin. Additionally oralternatively, an adhesive pad can be placed over some or all of thesensor system after sensor insertion is complete to ensure adhesion, andoptionally to ensure an airtight seal or watertight seal around thewound exit-site (or sensor insertion site) (not shown). Appropriateadhesive pads can be chosen and designed to stretch, elongate, conformto, and/or aerate the region (e.g., host's skin). The embodimentsdescribed with reference to FIGS. 2A and 2B are described in more detailwith reference to U.S. Pat. No. 7,310,544, which is incorporated hereinby reference in its entirety. Configurations and arrangements canprovide water resistant, waterproof, and/or hermetically sealedproperties associated with the mounting unit/sensor electronics moduleembodiments described herein.

Referring back to FIG. 1, the sensor module 8 is in data communicationwith typically one, but possibly more than 1 recording device 14, 16,18, 20, 22. These devices may be configured to receive and record atleast some of the data stream representative of the hosts's analyteconcentration produced and transmitted by the sensor module 8. Therecording device 14, 16, 18, 20, 22 may be configured to performreal-time processing and calibration of the data received by the sensormodule 8. This may be termed “prospective” processing, as it allowsimmediate feedback and an ability to prompt the user to take some actionin response to current levels of analyte concentration. Predictions ofanalyte concentration in the near future can also be made based onanalysis and processing of current and recent past data received by therecording device 14, 16, 18, 20, 22. It will be appreciated that suchprospective processing can be partially or fully performed in the sensormodule 8 if desired, and may in general be distributed in any suitablemanner throughout the components of the system. As will be discussedfurther below, these devices 14, 16, 18, 20, 22 typically incorporatedisplays 24, 26, 28, 30, and 32 respectively.

In some embodiments, one such device is a small (e.g., key fob)recording device 14 that is configured to record at least some of thesensor information, and may be configurable to display information suchas an analyte concentration value and a trend arrow. In general, a keyfob device is a small hardware device sized to fit on a key chain.Although in some embodiments such a recording device may be formed as orbe incorporated into a wrist band, a hang tag, a belt, a necklace, apendent, a piece of jewelry, an adhesive patch, a pager, anidentification (ID) card, and the like, all of which are included by thephrase “small recording device” and/or “key fob device” herein.

In some embodiments, the recording device is a hand-held display device16 configured to record sensor information including an analyteconcentration. Such a device may be configurable to display a graphicalrepresentation of the analyte concentration over time such as a previous1, 3, 5, 6, 9, 12, 18, or 24-hours of sensor data. In some embodiments,the hand-held device 16 is configurable to display a trend graph orother graphical representation, a numeric value, an arrow, and/or toalarm the host. U.S. Patent Publication No. 2005/0203360, which isincorporated herein by reference in its entirety, describes andillustrates some examples of display of data on a hand-held recordingdevice.

In some embodiments, a mobile phone or PDA 18 is configured to operateas a recording device. An application program may be provided on ordownloaded to the device 18 to configure it to receive and record sensorinformation from the sensor module 8. With an appropriate applicationprogram, the mobile phone or PDA 18 may be configured to provide displayof sensor data and alarm in manner similar to the hand-held device 16.

In some embodiments, a recording device is personal computer (PC) 20configured to record sensor information. The PC 20 may have softwareinstalled, wherein the software enables recording, and/or display,and/or performs data analysis (retrospective processing) of the historicsensor information. In some embodiments, a hardware device can beprovided (not shown), wherein the hardware device (e.g., dongle/adapter)is configured to plug into a port on the PC to enable wirelesscommunication between the sensor electronics module 8 and the PC 20.

Another common component of an analyte measuring and monitoring systemis a single point analyte monitor (which may be referred to as a BGMdevice). One example of a recording device including a single pointanalyte monitor is denoted 22 in FIG. 1. With these devices, the usermay obtain a blood sample by pricking their finger, and place the sampleon a test strip 23 which is inserted into the single point monitor 22.The single point monitor analyzes colorimetric or other properties ofthe test strip to derive a blood analyte concentration. Prior to thedevelopment and commercialization of continuous measuring systems (whichmay be referred to as CGM systems), single point monitors 22 were thesole method available for a diabetic to monitor and control glucoselevels. This required many unpleasant finger pricks in a day for apatient to control glucose levels properly. Single point monitors 22 arestill used in conjunction with CGM systems for calibration purposes andto provide an additional check on continuous system data. The number ofsingle point tests that need to be done in a day, however, isdrastically reduced when a CGM system is also used.

In some embodiments, a single point monitor 22 includes thecommunication and recording functionality of the other recording devices14, 16, 18, and 20 described above. In other embodiments, single pointanalyte measurement functionality of single point monitor 22 can beincorporated into the recording devices 14, 16, 18, 20 described above.In either case, a device 14, 16, 18, 20, 22 can provide the functionsboth a BGM device and CGM recorder in a single device. In oneembodiment, a common housing integrates a single point analyte monitor(416 in FIGS. 3 and 4) and device electronics useful for receiving,processing, and displaying continuous analyte data from module 8. Such adevice may measure and record single point analyte monitor data andreceive, process, and record continuous analyte sensor data. Theprocessing may include calibration of the continuous sensor data usingthe single point monitor data. In some embodiments, the communication,recording, and processing circuitry is not in the same housing as thesingle point monitor, but they are in communication with one anotherwith a wired or wireless connection. It will be appreciated that it issomewhat arbitrary whether a device is described as a BGM device withCGM functionality, or a CGM device with BGM functionality. Fordescription purposes herein, all devices with CGM functionality arereferred to as recording devices, which devices may also include BGMfunctionality.

In some embodiments, a recording device is an on-body device that issplittable from, releasably attached to, and/or dockable to the sensorhousing (mounting unit, sensor pod, or the like). In some embodiments,release of the on-body recording device turns the sensor off; in otherembodiments, the sensor housing comprises sufficient sensor electronicsto maintain sensor operation even when the on-body recording device isreleased from the sensor housing.

It is contemplated that in some embodiments, wireless transmissions mayallow for communication not only between one or more recording devices14, 16, 18, 20, 22 and one continuous analyte sensor module 8, but forcommunication between one or more recording devices 14, 16, 18, 20, 22and a plurality of sensor modules, so that a recording device canreceive a plurality of data streams from a plurality of sensor modules8.

Any of the recording devices 14, 16, 18, 20, 22 can be configured toprovide alerts or alarms to the host under certain defined measurementand operating conditions. Each alert may be based on one or more alertconditions that indicate when the respective alert should be triggered.For example, a hypoglycemic alert may include alert conditionsindicating a minimum glucose level. The alert conditions may also bebased on transformed sensor data, such as trending data, and/or sensordata from multiple different sensors (e.g. an alert may be based onsensor data from both a glucose sensor and a temperature sensor). Forexample, a hypoglycemic alert may include alert conditions indicating aminimum required trend in the host's glucose level that must be presentbefore triggering the alert. The term “trend,” as used herein refersgenerally to data indicating some attribute of data that is acquiredover time, e.g., such as calibrated or filtered data from a continuousglucose sensor. A trend may indicate amplitude, rate of change,acceleration, direction, etc., of data, such as sensor data, includingtransformed or raw sensor data.

Each of the alerts may be associated with one or more actions that areto be performed in response to triggering of the alert. Alert actionsmay include, for example, activating an alarm, such as displayinginformation on a display of the sensor electronics module or activatingan audible or vibratory alarm coupled to the sensor electronics module,and/or transmitting data to one or more display devices external to thesensor module.

In some embodiments, clinical risk alerts are provided that includealert conditions that combine intelligent and dynamic estimativealgorithms that estimate present or predicted danger with greateraccuracy, more timeliness in pending danger, avoidance of false alarms,and less annoyance for the patient. In general, clinical risk alertsinclude dynamic and intelligent estimative algorithms based on analytevalue, rate of change, acceleration, clinical risk, statisticalprobabilities, known physiological constraints, and/or individualphysiological patterns, thereby providing more appropriate, clinicallysafe, and patient-friendly alarms. U.S. Patent Publication No.2007/0208246, which is incorporated herein by reference in its entirety,describes some systems and methods associated with the clinical riskalerts (or alarms) described herein. In some embodiments, clinical riskalerts can be triggered for a predetermined time period to allow for theuser to attend to his/her condition. Additionally, the clinical riskalerts can be de-activated when leaving a clinical risk zone so as notto annoy the patient by repeated clinical alarms (e.g., visual, audibleor vibratory), when the patient's condition is improving. In someembodiments, dynamic and intelligent estimation determines a possibilityof the patient avoiding clinical risk, based on the analyteconcentration, the rate of change, and other aspects of the dynamic andintelligent estimative algorithms. If there is minimal or no possibilityof avoiding the clinical risk, a clinical risk alert will be triggered.However, if there is a possibility of avoiding the clinical risk, thesystem may be configured to wait a predetermined amount of time andre-analyze the possibility of avoiding the clinical risk. In someembodiments, when there is a possibility of avoiding the clinical risk,the system may be further configured to provide targets, therapyrecommendations, or other information that can aid the patient inproactively avoiding the clinical risk.

Such a system can be configured to operate in a more flexible and usefulmanner than has previously been performed by such systems. In someembodiments, the system may include an operational mode that preventsthe display of CGM data in real-time. This “blinding” of analyteconcentration values associated with CGM data may be advantageous forcertain diabetics whose doctors believe that real-time CGM data displayis not appropriate. In some cases, a physician may use a CGM system witha patient where the patient does not have access to the data for theperiod of time that the sensor module 8 is installed. Instead, therecording device 14, 16, 18, 20, 22 stores the data for laterdownloading, further processing, and viewing by the physician to makerecommendations or diagnoses for the patient. This later processing andreview of previously acquired data may be termed “retrospective”processing as it is useful provide advice on future behavior, but doesnot provide any information regarding current analyte levels.Conventionally, in such a system no prospective processing or alarmfunctionality is utilized.

This conventional method of blinded analyte monitoring fails to takeadvantage of all the capabilities of a CGM system. In some embodiments,therefore, even when operating in a blinded mode, the CGM functionalityof the system can be utilized to perform other useful functions withoutdisplaying data from the sensor module 8 to the user. The additionalfeatures provided by incorporation of CGM technology may include, forexample, prospective processing of the analyte data and configurablealarms that may warn a patient of a pending hyperglycemic orhypoglycemic event and configurable, intelligent alerts that prompt thepatient to perform a single point analyte measurement (e.g., a bloodglucose measurement) at certain times that are determined to be optimalby the device electronics. In a blinded mode, the recorder 14, 16, 18,20 may be configured to display analyte concentration values measured bythe single point analyte monitor. It may also be configured toprospectively process analyte data, and trigger alarms based on theprospective processing, but not display any analyte concentration valuesassociated with the data stream transmitted from the continuous analytesensor 110.

In some embodiments, a single recording device 14, 16, 18, 20, 22 iscapable of operating in both a blinded mode, in which only analyteconcentration values measured by the single point analyte monitor aredisplayed while the continuous data is prospectively calibrated andprocessed, and an unblinded mode, in which analyte concentration valuesmeasured by both the continuous analyte sensor and the single pointanalyte monitor are displayed. In the blinded mode, the device may beused as a diagnostic tool (e.g., by a physician to determine whether apatient is a diabetic). Furthermore, the blinded mode may also providethe physician with a tool for determining necessary basal adjustmentsand for obtaining a baseline of a patient's glycemic control. In theunblinded mode, the patient can learn from watching glucoseconcentration trends throughout the day. For example, in the unblindedmode, the device may provide the patient with a tool to achieve certaindiabetes goals, such as, achieving A1c targets without addinghypoglycemia, reducing hypoglycemia, and reducing glucose variability.In either mode, data from the continuous analyte sensor is stillrecorded, and this data may be subsequently utilized for retrospectiveprocessing and analysis.

FIG. 3 is an exemplary block diagram illustrating various elements ofone embodiment of a sensor module 8 and recording device 14, 16, 18, 20,22. The sensor module 8 may include a sensor 312 (also designated 10 inFIG. 1) coupled to a sensor measurement circuit 310 for processing andmanaging sensor data. The sensor measurement circuit 310 may be coupledto a processor 314 (part of item 12 in FIG. 1). In some embodiments, theprocessor 314 may perform part or all of the functions of the sensormeasurement circuit 310 for obtaining and processing sensor measurementvalues from the sensor 312. The processor may be further coupled to atransceiver 316 (part of item 12 in FIG. 1) for sending sensor data andreceiving requests and commands from an external device, such as therecording device 14, 16, 18, 20, 22. The sensor module 8 may furtherinclude a memory 318 (part of item 12 in FIG. 1) for storing andtracking sensor data.

The recording device 14, 16, 18, 20, 22 may be used for alerting andproviding sensor information to a user, and may include a processor 330for processing and managing sensor data. The display device 14, 16, 18,20, 22 may include a display 332 and a memory 334 for displaying,storing and tracking sensor data respectively. The display device 14,16, 18, 20, 22 may further include a transceiver 338 for receivingsensor data and for sending requests, instructions, and data to thesensor module 8. As described above, the recording device 14, 16, 18,20, 22 may incorporate a single point analyte monitor 416 that is incommunication with the processor 330.

The electronics associated with some embodiments of a recording device14, 16, 18, 20, 22 are described in more detail below with reference toFIG. 4. In one embodiment, analyte (e.g., glucose) from a biologicalsample produces a current flow at a working electrode of the device 120,with equal current provided by a counter electrode in a referencecircuit. The current is converted in an analog section by a current tovoltage converter to a voltage, which is inverted, level-shifted, anddelivered to an A/D converter in the processor (see FIG. 4). As part ofthe calibration, the processor can set the analog gain via its controlport. The A/D converter is preferably activated at one-second intervals.The processor looks at the converter output with any number of patternrecognition algorithms known to those skilled in the art until ananalyte peak is identified. A timer is then activated for about 30seconds at the end of which time the difference between the first andlast electrode current values is calculated. This difference is thendivided by the value stored in the memory during instrument calibrationand is then multiplied by the calibration analyte concentration. Theresult includes a calibrated analyte concentration value that ismeaningful to a user, and useful in calibrating the data stream from thecontinuous analyte sensor 110, for example.

FIG. 4 is a block diagram that illustrates device electronics 150 in oneembodiment. A quartz crystal 476 is operably connected to an RFtransceiver 478, which together function to receive and synchronize datastreams 440 via an antenna 480 (for example, transmission 440 from theRF transceiver 478) from a continuous analyte sensor. Once received, aprocessor 482 processes the signals, such as described below.

In one embodiment, the processor 482 is the central control unit thatprovides the processing, such as storing data, analyzing continuousanalyte sensor data stream, analyzing single point analyte values,accuracy checking, checking clinical acceptability, calibrating sensordata, downloading data, and controlling the user interface by providingprompts, messages, warnings and alarms, or the like. The ROM 484 isoperably connected to the processor 482 and provides semi-permanentstorage of data, storing data such as device ID and programming toprocess data streams (for example, programming for performingcalibration and other algorithms described elsewhere herein). SRAM 488is used for the system's cache memory and is helpful in data processing.For example, the SRAM stores information from the continuous analytesensor and the single point analyte monitor for later recall by the useror a doctor; a user or doctor can transcribe the stored information at alater time to determine compliance with the medical regimen or acomparison of analyte concentration to medication administration (forexample, this can be accomplished by downloading the information throughthe pc com port 490). In addition, the SRAM 488 can also store updatedprogram instructions and/or patient specific information. In somealternative embodiments, memory storage components comparable to ROM andSRAM can be used instead of or in addition to the preferred hardware,such as dynamic RAM, non-static RAM, rewritable ROMs, flash memory, orthe like.

A battery 492 is operably connected to the processor 482 and providespower for the device. In one embodiment, the battery is a standard AAAalkaline battery, however any appropriately sized and powered batterycan be used. In some embodiments, a plurality of batteries can be usedto power the system. In some embodiments, a power port (not shown) isprovided permit recharging of rechargeable batteries. A quartz crystal494 is operably connected to the processor 482 and maintains system timefor the computer system as a whole.

A PC communication (com) port 490 can be provided to enablecommunication with systems, for example, a serial communications port,USB connector, or the like, which allows for communicating with anothercomputer system (for example, PC, PDA, phone, server, or the like). Inone exemplary embodiment, the device is able to download historical datato a physician's PC for retrospective analysis by the physician. The PCcommunication port 490 can also be used to interface with other medicaldevices, for example pacemakers, implanted analyte sensor patches,infusion devices, telemetry devices, or the like.

Electronics associated with the single point analyte monitor 416 areoperably connected to the processor 482 via a wired or wirelessconnection 424. The electronics include a potentiostat 418 in oneembodiment that measures a current flow produced at the workingelectrode of the single point analyte monitor 416 when a biologicalsample is placed on the sensing membrane. The current may then convertedinto an analog signal by a current to voltage converter, which can beinverted, level-shifted, and sent to an A/D converter. The processor 420can set the analog gain via its control port (not shown). The A/Dconverter is preferably activated at one-second intervals. The processor420 looks at the converter output with any number of pattern recognitionalgorithms known to those skilled in the art until an analyte peak isidentified. A timer is then preferably activated for about 30 seconds atthe end of which time the difference between the first and lastelectrode current values is calculated. This difference is then dividedby the value stored in the memory during instrument calibration and isthen multiplied by the calibration analyte concentration. The analytevalue in milligram per deciliter, millimoles per liter, or the like, isthen stored in the processor, displayed on the user interface, used tocalibrate of the analyte sensor data stream, downloaded, etc.

In one embodiment, the user interface 496 comprises a keyboard 498,speaker 400, vibrator 402, backlight 402, liquid crystal display (LCD)406, and one or more buttons 408. The components that comprise the userinterface 496 provide controls to interact with the user. The keyboard498 can allow, for example, input of user information about anindividual, such as mealtime, exercise, insulin administration, andreference analyte values. The speaker 400 can provide, for example,audible signals or alerts for conditions such as present and/orpredicted hyper- and hypoglycemic conditions. The vibrator 402 canprovide, for example, tactile signals or alerts for reasons such asdescribed with reference to the speaker, above. The backlight 404 can beprovided, for example, to aid the user in reading the LCD in low lightconditions. The LCD 406 can be provided, for example, to provide theuser with visual data output. In some embodiments, the LCD is atouch-activated screen. The buttons 408 can provide for toggle, menuselection, option selection, mode selection, and reset, for example. Insome alternative embodiments, a microphone can be provided to allow forvoice-activated control.

As described elsewhere herein, in some embodiments, determination as towhen to trigger a configurable alarm, alert, or prompt may be based atleast in part on information associated with the data stream from thecontinuous analyte sensor. Configurable alarms can mitigate costs byprotecting patients against potentially dangerous low and high glucoseexcursions and possible hospitalization. In some embodiments, one ormore alerts are associated with the device electronics. For example,each alert may include one or more alert conditions that indicate whenthe respective alert has been triggered. For example, a hypoglycemicalert may include alert conditions indicating a minimum glucose level.The alert conditions may also be based on transformed sensor data, suchas trending data, and/or sensor data from multiple different sensors(e.g., an alert may be based on sensor data from both a glucose sensorand a temperature sensor). For example, a hypoglycemic alert may includealert conditions indicating a minimally required trend in the host'sglucose level that has to be present before triggering the alert. Theterm “trend,” as used herein, refers generally to data indicating someattribute of data that is acquired over time, e.g., calibrated orfiltered data from a continuous glucose sensor. A trend may indicateamplitude, rate of change, acceleration, direction, etc., of data, suchas sensor data, including transformed or raw sensor data.

In one embodiment, each of the alerts is associated with one or moreactions that are to be performed in response to triggering of the alert.Alert actions may include, for example, activating an alarm, such asdisplaying information on the user display of the device or activatingaudible or vibratory alarm coupled to the device.

In some embodiments, clinical risk alerts are provided that includealert conditions that combine intelligent and dynamic estimativealgorithms that estimate present or predicted danger with greateraccuracy, more timeliness in pending danger, avoidance of false alarms,and less annoyance for the patient. In general, clinical risk alertsinclude use of dynamic and intelligent estimative algorithms based atleast in part on data collected from the continuous analyte sensor, suchas, analyte concentration value, rate of change of concentration, rateof acceleration of concentration, etc., thereby providing moreappropriate, clinically safe, and patient-friendly alarms. Otherinformation, such as, clinical risk, statistical probabilities, knownphysiological constraints, time of day, mealtime information, exerciseinformation, insulin administration information, and/or individualhistorical patterns, and the like, may also be used for determiningclinical risk alerts. U.S. Patent Publication No. US-2007-0208246-A1,which is incorporated herein by reference in its entirety, describessome systems and methods associated with the clinical risk alerts (oralarms) described herein. In some embodiments, in response to theclinical risk alerts, prompts or messages can be displayed on the userinterface 496 to inform the user about certain procedures, such as“perform another fingerstick measurement.” Furthermore, the analyteconcentration value measured by the single point analyte monitor can beindividually displayed.

In some embodiments, alarms, alerts, or prompts of the device may beactivated based on an estimation algorithm that can extrapolate orestimate values for a future time period, such as described in U.S.Patent Publication No. US-2005-0203360-A1, which is incorporated hereinby reference in its entirety. For example, the device electronics may beconfigured to estimate glucose concentration values for an upcoming15-minute time period. If a potential hypoglycemic or hyperglycemicevent is estimated or forecasted based on the estimation algorithm, thedevice may be configured to warn the patient (e.g., through an alarm oralert) of the present or upcoming event and prompt the patient to take acertain recommended action (e.g., administer insulin).

The sensor data collected from the continuous analyte sensor may beprocessed prospectively, retrospectively, or both. Prospectiveprocessing of sensor data may involve matching sensor data from thecontinuous analyte monitor with reference glucose values from the singlepoint analyte monitor, such as described in U.S. Pat. No. 7,778,680,which is incorporated herein by reference in its entirety. Withretrospective processing of sensor data collected from the continuousanalyte sensor and/or the single point analyte monitor are stored in amemory of the device for retrospective analysis. For instance, via thePC communication port 490, the stored data can be transferred ordownloaded to another device (e.g., a device, such as a computer,compatible multiple data management systems such as DexCom Data Manager,Diasend, or the like) so that retrospective data analysis may beperformed. In some embodiments, the device electronics or a computer,which has received sensor data from the device, compares sensor datafrom two different analysis time periods (e.g., a first time periodduring which the device was in a blinded mode and a second time periodduring which the device was a in an unblinded mode). A performancereport is then prepared that discloses changes in sensor data over thevarious time periods. The performance report may include one or moreperformance reports, such as graphs, charts, tables, etc., that includeand/or otherwise illustrate the determined performance indicators, whichmay be displayed on a display device of the host computing device orother display device. Depending on the embodiment, the analysis timeperiods may be any time period, such as one day, one week, two weeks,three weeks, one month, two months, three months, six months, one year,or any other time period. Thus, the performance report module providesthe host with reports that indicate changes in sensor data over varioustime periods. A more detailed description regarding comparing sensordata from two time periods is described in U.S. patent application Ser.No. 12/770,618, filed on Apr. 29, 2010 and entitled “PERFORMANCE REPORTSASSOCIATED WITH CONTINUOUS SENSOR DATA FROM MULTIPLE ANALYSIS TIMEPERIODS”, which is incorporated herein by reference in its entirety

In another embodiment, the device may come with a USB connector, or thelike, that enables connection with a computer having software foranalyzing data (e.g., DexCom Data Manager software). In addition, thedevice and/or the computer may be adapted for plug-and-play, i.e.,automatic downloading of and retrospective analysis of sensor data fromthe continuous analyte sensor, upon connection of the device to thecomputer.

In some embodiments, downloading of CGM data and retrospective analysismay be performed in conjunction with a computer network. Referring toFIG. 5, a block diagram is illustrated of a network on which such amethod could be employed. This system operates with a plurality ofcomputers which are coupled together on a network, such as the Internet550, or other communications network. FIG. 5 depicts a network thatincludes user computers 510, 520, and 530 that communicate with one ormore web servers 570 though communication links that include theInternet 550. The user computers 510, 520, and 530 may be any type ofcomputing device that allows a user to interactively browse theWorld-Wide-Web, such as a personal computer (PC) that includes a webbrowser (e.g., Microsoft Internet Explorer™ or Google Chrome™). Suitableuser computers equipped with browsers are available in manyconfigurations, including handheld devices (e.g., Apple iPhone™, GoogleAndroid, or RIM Blackberry), personal computers (PC), laptop computers,workstations, television set-top devices, tablets, and so forth.

One or more recording devices 14, 16, 18, 20, 22 may also be configuredfor communication with the network. Connectivity with awide-area-network such as the Internet may be inherently provided whenthe recording device is implemented as a mobile phone 18. For otherforms of recording device, such as hand-held recording device 16,network communication functionality can be incorporated by including inthe device any of a variety of conventional communication circuitsnormally used in mobile phones and computers with networkingcapabilities.

In one advantageous embodiment, the recording devices 14, 16, 18, 20, 22are configured to download CGM data, which may be raw, partially orfully processed, to a web server 570 which may host or otherwise accessa database 580 that stores the downloaded CGM data. The web server(s)570 includes a server computer running a web interface application andcapable of selectively delivering data files, such as HTML files, touser computers using a protocol such as HTTP. With this networked CGMdata storage, a physician or other caregiver may have access to apatient's CGM data from any device with networked connectivity such asdevices 510, 520, and 530. Furthermore, even though the user may nothave access to the CGM data due to the system operating in a blindedmode, a physician or other caretaker could have immediate access to theCGM information at any time from any network connected device.

Web server 570 may also dynamically generate content for delivery touser computers in response to a request from a user computer. Thecontent may be generated by web server 570 directly, or may be generatedby other computers linked to web server 570 in response to a requestfrom web server 570. Web server 570 may then forward the requestedcontent to a user computer over network 550.

Web server applications may be coded in various programming languages,such as Java, Perl, C#, C, or C++, and are customized to run on theirrespective servers 570. Web servers 570 may also include applicationsutilizing a variety of specialized application languages such asMicrosoft Silverlight™, or Adobe Flash™ to implement user interfacesdisplayed on the user computers. These specialized applications may beintegrated with files or dynamic content provided by Web server 570 tothe user computers in response to a request from those user computers.Web server applications, such as those running on web server 570, mayalso interface with a database application, such as a SQL Server™ enginefrom Microsoft Corporation, Oracle™ database engine, or MySQL as part oftheir architecture. These database applications may control or managedatabase 580.

Web applications running on web server 570 may access a database of webpages, distributable applications, and other electronic files containinginformation of various types. Web pages or other electronic files may beviewed on the displays of the user computers by a suitable applicationprogram residing on a user computer, such as a browser, or by adistributable application provided to a user computer by the web server570. It should be appreciated that many different user computers, manydifferent web servers, and many different application servers of varioustypes may be communicating with each other at the same time.

FIG. 6 is a simplified block diagram illustrating the internal softwarearchitecture of one embodiment of web server 570. Web server 570 may beimplemented using one of several standard hardware web server platformsincluding general purpose computers or specialized web server computersfrom any one of a number of manufacturers to include Hewlett Packard,Apple, Dell, IBM, or the like. These web server hardware platforms mayrun any one of a number of operating systems 630 to include MicrosoftWindows Server, Linux, or several other versions of Unix. Web Server 570may also be virtualized within a server virtualization system such asVMWare to enable multiple web servers or other applications to operateon one individual computer.

Running on these hardware and operating system web server platforms maybe software applications including what is known in the art as anapplication server 610. Applications servers may include Apache Tomcat,Websphere, or Jboss. Simplified web application architectures may alsobe used, to include http servers such as an Apache http server runningcgi scripts, or open source applications such as Drupal or Jumla.

As illustrated in FIG. 2, Application Server 610 running on web server570 interacts via a network port 650 with a network 550. Applicationserver 610 may receive requests from the network 150 generated by usercomputers of FIG. 5 over network port 650. Within Application server 610may be a web container containing one or more web application programsas described above. These applications may respond to the networkrequests generated by user computers to deliver web content back to usercomputers over network 550. These application programs may includeinstructions that configure a processor running in web server 570 toperform the methods of one or more operative embodiments describedherein.

Web server 570 also includes a file system 620. Application server 620may read and write data to file system 620 in order to respond torequests from user computers over network 550. File system 620 may storestatic files including html files that define one or more aspects of auser interface provided by Application Server 610 to user computers overnetwork 550. File system 620 may also store instructions of the webapplications described above that cause the processor running in webserver 570 to perform the method of one or more of the operativeembodiments described in this application.

FIG. 7 is a flowchart illustrating a method of operating a continuousanalyte monitoring system. This flowchart illustrates an embodimentwherein a continuous glucose monitoring system is used in a blindedmode, but still provides alarms or alerts to a user of the system.

Referring now to FIG. 7, at block 710 a recording device receives a datastream associated with glucose concentration in a host from a continuousglucose sensor. At block 720 the information from the continuous glucosesensor may be processed by the recording device. This processing mayinclude calibration processing, derivations of glucose concentrations,comparing received values or processed values to thresholds, computingtrends, etc. At block 730, the recording device stores the data streamand/or processed values derived at least in part from the data streamwithout displaying any data directly or derived from the data stream tothe user of the system. At block 740, an alarm is triggered based atleast in part on information associated with the data stream. It will beappreciated that although FIG. 7 is directed to glucose monitoring, themethod described can be applied to any analyte.

As described above, a recording device can incorporate or otherwise bein communication with a single point monitor. In some embodiments, therecording device can be configured to display results from the singlepoint monitor even as it hides data from the continuous analyte sensor.In addition, the recording device can be configured to automaticallydownload recorded continuous analyte data to networked storage foraccess by a physician or other caregiver.

The systems and methods described above have a variety of advantageousfeatures. The recorded device can be configured to hide analyte datafrom those subjects that a physician determines are better off withouthaving access, yet the recording device can still provide alarms basedon the data being recorded using prospective calibration, diagnosticsand/or other real-time data processing. Furthermore, the data can bemade available essentially immediately over the Internet or otherwide-area-network to physicians based on a retrospective analysis thatmay occur at the recording devices, at the web server or connecteddevice and/or on an application at the a local computer (e.g., webapplication at a physician's office). Therefore, both prospective andretrospective analysis can be occurring at the same time, with alarmcapability immediately available to the host based on the prospectiveprocessing, which data for retrospective processing and review isavailable to the physician or other caregiver at essentially any time.

In some embodiments, a single recording device can be selectivelyconfigured to operate in multiple modes. A first mode may be aconventional blinded mode. In this case, the recording device may beconfigured to display no data or perhaps only data taken from a singlepoint monitor, and may also be configured to provide no alarm functionseither. In a second mode, the recording device may operate as aconventional CGM system, where the user has access via the display toglucose values, trend graphs, and other representations of the databeing collected by the continuous glucose monitor. This mode may alsoinclude configurable alarm functions as is found in current CGM systems.In a third mode, the recording device may restrict user access to thedata being collected by the continuous analyte monitor, but still beconfigured to provide alarm functions to the user of the system.

While various embodiments of the invention have been described above,they have been presented by way of example only, and not by way oflimitation. Likewise, the various diagrams may depict an examplearchitectural or other configuration for the disclosure, which is doneto aid in understanding the features and functionality that can beincluded in the disclosure. The disclosure is not restricted to theillustrated example architectures or configurations, but can beimplemented using a variety of alternative architectures andconfigurations. Additionally, although the disclosure is described abovein terms of various exemplary embodiments and implementations, thevarious features and functionality described in one or more of theindividual embodiments are not limited in their applicability to theparticular embodiment with which they are described. They instead can beapplied, alone or in some combination, to one or more of the otherembodiments of the disclosure, whether or not such embodiments aredescribed, and whether or not such features are presented as being apart of a described embodiment. Thus the breadth and scope of thepresent disclosure should not be limited by any of the above-describedexemplary embodiments.

All references cited herein are incorporated herein by reference intheir entirety. To the extent publications and patents or patentapplications incorporated by reference contradict the disclosurecontained in the specification, the specification is intended tosupersede and/or take precedence over any such contradictory material.

Unless otherwise defined, all terms (including technical and scientificterms) are to be given their ordinary and customary meaning to a personof ordinary skill in the art, and are not to be limited to a special orcustomized meaning unless expressly so defined herein.

Terms and phrases used in this application, and variations thereof,especially in the appended claims, unless otherwise expressly stated,should be construed as open ended as opposed to limiting. As examples ofthe foregoing, the term “including” should be read to mean “including,without limitation,” “including but not limited to,” or the like; theterm “comprising” as used herein is synonymous with “including,”“containing,” or “characterized by,” and is inclusive or open-ended anddoes not exclude additional, unrecited elements or method steps; theterm “having” should be interpreted as “having at least;” the term“includes” should be interpreted as “includes but is not limited to;”the term “example” is used to provide exemplary instances of the item indiscussion, not an exhaustive or limiting list thereof; adjectives suchas “known”, “normal”, “standard”, and terms of similar meaning shouldnot be construed as limiting the item described to a given time periodor to an item available as of a given time, but instead should be readto encompass known, normal, or standard technologies that may beavailable or known now or at any time in the future; and use of termslike “preferably,” “preferred,” “desired,” or “desirable,” and words ofsimilar meaning should not be understood as implying that certainfeatures are critical, essential, or even important to the structure orfunction of the invention, but instead as merely intended to highlightalternative or additional features that may or may not be utilized in aparticular embodiment of the invention. Likewise, a group of itemslinked with the conjunction “and” should not be read as requiring thateach and every one of those items be present in the grouping, but rathershould be read as “and/or” unless expressly stated otherwise. Similarly,a group of items linked with the conjunction “or” should not be read asrequiring mutual exclusivity among that group, but rather should be readas “and/or” unless expressly stated otherwise.

With respect to the use of substantially any plural and/or singularterms herein, those having skill in the art can translate from theplural to the singular and/or from the singular to the plural as isappropriate to the context and/or application. The varioussingular/plural permutations may be expressly set forth herein for sakeof clarity.

It will be further understood by those within the art that if a specificnumber of an introduced claim recitation is intended, such an intentwill be explicitly recited in the claim, and in the absence of suchrecitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to embodiments containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (e.g., “a” and/or “an” should typically be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations. In addition, evenif a specific number of an introduced claim recitation is explicitlyrecited, those skilled in the art will recognize that such recitationshould typically be interpreted to mean at least the recited number(e.g., the bare recitation of “two recitations,” without othermodifiers, typically means at least two recitations, or two or morerecitations). Furthermore, in those instances where a conventionanalogous to “at least one of A, B, or C, etc.” is used, in general sucha construction is intended in the sense one having skill in the artwould understand the convention (e.g., “a system having at least one ofA, B, or C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). It will be furtherunderstood by those within the art that virtually any disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, claims, or drawings, should be understood to contemplatethe possibilities of including one of the terms, either of the terms, orboth terms. For example, the phrase “A or B” will be understood toinclude the possibilities of “A” or “B” or “A and B.”

All numbers expressing quantities of ingredients, reaction conditions,and so forth used in the specification are to be understood as beingmodified in all instances by the term ‘about.’ Accordingly, unlessindicated to the contrary, the numerical parameters set forth herein areapproximations that may vary depending upon the desired propertiessought to be obtained. At the very least, and not as an attempt to limitthe application of the doctrine of equivalents to the scope of anyclaims in any application claiming priority to the present application,each numerical parameter should be construed in light of the number ofsignificant digits and ordinary rounding approaches.

Furthermore, although the foregoing has been described in some detail byway of illustrations and examples for purposes of clarity andunderstanding, it is apparent to those skilled in the art that certainchanges and modifications may be practiced. Therefore, the descriptionand examples should not be construed as limiting the scope of theinvention to the specific embodiments and examples described herein, butrather to also cover all modification and alternatives coming with thetrue scope and spirit of the invention.

What is claimed is:
 1. A system for monitoring glucose concentration,the system comprising: a continuous glucose sensor, the continuousglucose sensor configured to continuously measure glucose aconcentration of a host and output a data stream associated with theglucose concentration; and a device configured to operatively connectwith the continuous glucose sensor, the device comprising at least oneprocessor configured to process the data stream from the continuousglucose sensor to generate real-time measured glucose concentrationvalues and store the measure glucose concentration values in memory, anda user interface configured to display the measured glucoseconcentration values, wherein the device is configured for togglingbetween an unblinded mode allowing for display of real-time glucoseconcentration values associated with the continuous glucose sensor onthe user interface and a blinded mode preventing display of real-timeglucose concentration values associated with the continuous glucosesensor on the user interface and a network server configured to generatea computer-displayable performance report that includes a graphicalrepresentation of measured glucose concentration values over time,wherein the report graphically distinguishes glucose values measuredduring the unblinded mode from glucose values measured during theblinded mode identifies changes in sensor data over at least twodifferent time periods, wherein a first time period of the at least twotime periods is a time period when the device is in the blinded mode andwherein a second time period of the at least two time periods is a timeperiod when the device is in the unblinded mode.
 2. The system of claim1, wherein the at least one processor is configured to determine when totrigger an alarm, wherein the determination of when to trigger the alarmis based at least in part on information associated with the processeddata stream.
 3. The system of claim 1, wherein the alarm is configuredto warn a user of a pending hyperglycemic event or a pendinghypoglycemic event.
 4. The system of claim 1, wherein the at least oneprocessor is configured to determine when to prompt a user to perform asingle point glucose measurement, wherein the determination of when toprompt the user is based at least in part on information associated withthe processed data stream.
 5. The system of claim 1, wherein thecontinuous glucose sensor is an implantable device.
 6. The system ofclaim 1, wherein the device further includes a single point glucosemonitor configured to measure a glucose concentration in blood.
 7. Thesystem of claim 6, wherein the device further comprises a memory forrecording at least one of the data stream from the continuous analytesensor or measured glucose concentration values associated with thesingle point glucose monitor.
 8. The system of claim 1, wherein thedevice is configured to download data from the continuous analyte sensorto networked storage, and wherein the computing device is a remoteserver.
 9. The system of claim 1, wherein the device is configured tocompare a first time period of glucose values measured while the deviceis in the blinded mode and to a second time period of glucose valuesmeasured while the device is in the unblinded mode and graphicallyindicate a result of the comparison in the performance report.
 10. Asystem for monitoring glucose concentration, the system comprising: acontinuous glucose sensor, the continuous glucose sensor configured tocontinuously measure glucose a concentration of a host and output a datastream associated with the measured glucose concentration; and a deviceconfigured to operatively connect with the continuous glucose sensor,the device comprising at least one processor configured to process thedata stream from the continuous glucose sensor and a display screen,wherein the device is configured for toggling between an unblinded modeallowing for display of real-time glucose concentration valuesassociated with the continuous glucose sensor on the display screen anda blinded mode preventing display of glucose concentration valuesassociated with the continuous glucose sensor, and wherein the device isfurther configured to generate and display a performance report thatidentifies a first time period of measured glucose values while thedevice is in the blinded mode and a second time period of measuredglucose values while the device is in the unblinded mode, and provides acomparison of the first time period to the second time period.
 11. Thesystem of claim 10, wherein the device further includes a single pointglucose monitor and wherein the display is configured to display glucoseconcentration values associated with the single point glucose monitor inboth the unblended and blinded modes.
 12. The system of claim 11,wherein the single point glucose monitor is configured to measure aglucose concentration in blood.
 13. The system of claim 10, wherein theat least one processor is further configured to determine when totrigger an alarm, wherein the determination of when to trigger the alarmis based at least in part on information associated with the processeddata stream.
 14. The system of claim 10, wherein the alarm is configuredto warn a user of a pending hyperglycemic event or a pendinghypoglycemic event.
 15. The system of claim 10, wherein the continuousglucose sensor is an implantable device.
 16. The system of claim 10,wherein the device further comprises a memory for recording at least oneof the data stream from the continuous analyte sensor or measuredglucose concentration values associated with the single point glucosemonitor.
 17. A method for analyzing glucose concentration in a user, themethod comprising: receiving, from a continuous glucose sensor to adevice, a data stream associated with a measured glucose concentrationof a host; processing the data stream; recording in computer readablememory the data stream and/or information derived from or associatedwith the data stream; determining when to trigger an alarm, wherein thedetermining of when to trigger the alarm is based at least in part onthe data stream or information derived from or associated with the datastream; toggling the device between an unblinded mode and a blindedmode; initiating display on a display screen of the device real-timeglucose concentration values associated with the continuous glucosesensor while the device is in the unblinded mode; preventing initiationof display on the display screen of the device real-time glucoseconcentration values associated with the continuous glucose sensor whilethe device is in the blinded mode; generating, using at least oneprocessor, a performance report that displays measured glucoseconcentration values associated with the continuous glucose sensor overtime, wherein the performance report visually distinguishes glucoseconcentration values measured while the device is in the blinded modefrom glucose concentration values measured while the device is in theunblinded mode; and displaying the performance report on a computerdisplay.
 18. A method for monitoring an analyte concentration in a user,the method comprising: using a computing device, receiving, from acontinuous analyte sensor, a data stream associated with the analyteconcentration of the user; processing the data stream; recording thedata stream in memory of the computing device; preventing display of anyinformation associated with the data stream on the computing devicewhile the computing device is in a blinded mode; enabling display ofinformation associated with the data stream on the computing devicewhile the computing device is in an unblinded mode; triggering an alarmon the computing device based at least in part on information associatedwith the processed data stream; and generating, using at least oneprocessor, a performance report that identifies a first time period ofglucose values measured while the computing device is in the blindedmode and compares the glucose values of the first time period to asecond time period of glucose values measured while the computing deviceis in the unblinded mode.
 19. The method of claim 18, wherein theanalyte is glucose.
 20. The method of claim 19, wherein the alarmcomprises a prompt to a user to perform a single point glucosemeasurement.
 21. The method of claim 19, wherein the alarm comprises anotification of a hypoglycemic or hyperglycemic event.
 22. The method ofclaim 18, comprising transmitting the data stream or data derived fromthe data stream over a communication link to a computer network.
 23. Asystem for continuous monitoring of an analyte concentration in a host,the system comprising: a continuous analyte sensor; a recording deviceconfigured to receive a data stream from the continuous analyte sensorrepresentative of analyte concentration in the host, wherein therecording device is configurable to switch between a blinded mode thatenables a restriction of host access to data from the continuous analytesensor while still providing alarms to the host based on data from thecontinuous analyte sensor, and an unblinded mode that does not enablethe restriction while still providing alarms to the host based on datafrom the continuous analyte sensor; and a processing device configuredto: (i) identify a first time period of sensor data when the computingdevice is in the blinded mode and a second time period of sensor datawhen the computing device is in the unblinded mode, (ii) compare thefirst time period to the second time period, and (iii) generate aperformance report that includes a graphical representation of a resultof the comparison.
 24. The system of claim 23, comprising a single pointanalyte monitor.
 25. The system of claim 24, wherein the single pointanalyte monitor is integrated into the recording device.
 26. The systemof claim 25, wherein the recording device is configured to displayanalyte concentration values measured by the single point analytemonitor.
 27. The system of claim 23, wherein the recording device isconfigured to transmit the data stream or data derived from the datastream over a communication link to a computer network.
 28. The systemof claim 23, wherein the continuous analyte sensor is configured tosense glucose concentration.
 29. The system of claim 23, furthercomprising a computer display configured to display the performancereport.
 30. The system of claim 23, wherein the processor module isfurther configured to cause display of the performance report on acomputing device.